Vaccine Effectiveness against Omicron- Adults- Primary Series of monovalent BNT162b2 Vaccine
Page last reviewed 29 January 2023
Key Points
Key Points are meant to be a scientific, factual summary of the available information that relates solely to the Pfizer-BioNTech COVID-19 Vaccine, as supported by referenced publications within this section. Conclusions should not be drawn from the inclusion or absence of information.
Vaccine effectiveness (VE) of 1 or 2 doses of monovalent BNT162b2 vaccine has been evaluated against several outcomes of interest, such as confirmed and symptomatic COVID-19 infection, Emergency Department (ED)/Urgent Care (UC) visits, hospitalization, hospitalization/ICU admission or death, during a period of Omicron (B1.1.529, BA.1/2) predominance. (1-6)
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Omicron variant- lineage B1.1.529
- The Omicron variant (B.1.1.529) was initially identified in November 2021. Vaccine effectiveness (VE) against Omicron confirmed infection (1, 2) and other outcomes, such as Emergency Department (ED)/ Urgent care (UC) visits (3), hospitalization (2-5), and death (2, 4), has been evaluated in Real World Evidence studies.
- VE % (95% CI) against Omicron outcomes of interest has been reported in recipients of 2 doses of monovalent BNT162b2 compared to unvaccinated individuals, at the listed times post last vaccine dose, are detailed below. The listed studies cannot be compared due to differences in study design and methodology.
Table Data
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Confirmed infection
| VE% (95% CI) of 2 doses of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated] |
|---|
| Adults ≥ 18 years |
| ≥ 14 days: 41 (-17- 87)(1) Median 314 days: 25 (22-29)(2) |
ED visits
| VE% (95% CI) of 2 doses of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated] |
|---|
| Adults ≥ 18 years |
| ≥ 7 days: 47 (40–54)(3) ≥ 9 months: 31 (16–43)(3) |
Hospitalization
| VE% (95% CI) of 2 doses of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated] |
|---|
| Adults ≥ 18 years |
| ≥ 7 days: 62 (53–69)(3) ≥ 9 months: 41 (21–55)(3) Median 326 days: 53 (48-58)(2) |
Death
| VE% (95% CI) of 2 doses of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated] |
|---|
| Adults ≥ 18 years |
| Median 338 days: 51 (38-62)(2) |
Omicron variant- sublineage BA.1/ BA.2
- The effectiveness of protection provided by previous Omicron (B1.1.529) infection, vaccination with 2 doses of monovalent BNT162b2 and hybrid immunity (previous omicron infection and vaccination with BNT162b2) against symptomatic BA.1/BA.2 and any Omicron infection has been analyzed in a matched, test-negative, case-control study. (6)
- The observed effectiveness of previous infection with Omicron lineage B1.1.529 alone against symptomatic BA.2 infection was 46.1% (95% CI, 39.5-51.9) and 50.2% (95% CI, 38.1-59.9) against symptomatic BA.1 infection.
- VE of 2 vaccine doses and no previous infection was -1.1% (95% CI, -7.1 to 4.6) against symptomatic BA.2 infection and -4.9% (95% CI, -16.4- 5.4) against symptomatic BA.1 infection; however, the majority of participants received 2nd vaccine dose more than 6 months earlier.
- Previous infection alone, BNT162b2 vaccination alone and hybrid immunity all showed >70% effectiveness against severe, critical, or fatal COVID-19 infection.
- VE% (95% CI) of 2 doses of monovalent BNT162b2, at listed times post last vaccine dose, in immunocompetent adults, during a period of BA.1/BA.2 predominance, against symptomatic infection (4, 6), and hospitalization or death (4) were reported:
Table Data
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Symptomatic infection
| Variant | VE% (95%CI) of 1 dose of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated] |
VE% (95%CI) of 2 doses of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated] |
|---|---|---|
| BA.1 | ≥ 14 days: 39 (2-62)(4) | ≥ 14 days: -5 (-16- 5) (6) 1-3 months: 47 (33- 57) (4) 4-6 months: 9 (-4- 20) (4) ≥ 7 months: -18 (-28 to -8) (4) |
| BA.2 | ≥ 14 days: 36 (12-54)(4) | ≥ 14 days: -1 (-7- 5) (6) 1-3 months: 52 (43- 59) (4) 4-6 months: 12 (4-20) (4) ≥ 7 months: -12 (-19 to -6) (4) |
Hospitalization or death
| Variant | VE% (95%CI) of 1 dose of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated] |
VE% (95%CI) of 2 doses of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated] |
|---|---|---|
| BA.1 and BA.2 | Time not reported: 41 (-199-88)(4) | 1-6 months: 70 (45-84) (4) ≥ 7 months: 78 (68- 84) (4) |
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- VE against BA.1 and BA.2 symptomatic infection was similar and waned rapidly starting at 4 months after 2nd vaccine dose; VE against hospitalization or death was durable after a 2nd dose. (4)
- Waning VE has been noted against Omicron infection, observed at > 3–6 months after receipt of 2nd dose of monovalent BNT162b2 COVID-19 vaccine. (3, 4)
- BNT162b2 vaccine monovalent COVID-19 vaccine, in the studies described in this summary, has been associated with reduction of risk against more severe Omicron outcomes, such as hospitalization or death. (3, 4, 6)
References: (1) Richterman, (2) Sharma, (3) Tartof, Lancet Respir Med 2022, (4) Cheimatelly, (5) Link-Gelles, (6) Altarawneh
Publications have reported different definitions of COVID-19 outcomes. Definitions can be found under Primary Endpoints and Definitions for each study below.
